Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to A-G Profen. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .

To lessen stomach upset, you may take this medicine with food or milk .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets and suspension):

For fever:

Children over 2 years of age—Use and dose must be determined by your doctor.

Children 6 months of age up to 2 years—Dose is based on body weight and body temperature, and must be determined by your doctor. For fever lower than 102.5 °F (39.2 °C), the dose usually is 5 milligrams (mg) per kilogram (kg) (about 2.2 mg per pound) of body weight. For higher fever, the dose usually is 10 mg per kg (about 4.5 mg per pound) of body weight. The medicine may be given every six to eight hours, as needed, up to 40 mg per kg per day.

Infants younger than 6 months of age—Use and dose must be determined by your doctor .

For menstrual cramps:

Adults—400 milligrams (mg) every four hours, as needed.

Children—Use and dose must be determined by your doctor .

For mild to moderate pain:

Adults and teenagers—400 milligrams (mg) every four to six hours, as needed.

Children over 6 months of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 10 milligrams (mg) per kilogram (kg) of body weight every six to eight hours, as needed, up to 40 mg per kg per day.

Infants younger than 6 months of age—Use and dose must be determined by your doctor .

For osteoarthritis and rheumatoid arthritis:

Adults and teenagers—1200 milligrams (mg) up to 3200 mg per day divided into three or four equal doses.

Children—Dose is based on body weight and must be determined by your doctor. The dose usually is 30 milligrams (mg) to 40 mg per kilogram (kg) of body weight per day, divided into three or four doses.

Infants younger than 6 months of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

A-G Profen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal pain

acid or sour stomach

belching

bloating

cloudy urine

decrease in amount of urine

decrease in urine output or decrease in urine-concentrating ability

diarrhea

difficulty having a bowel movement (stool)

excess air or gas in stomach or intestines

full feeling

heartburn

indigestion

itching skin

pain or discomfort in chest, upper stomach, or throat

pale skin

passing gas

nausea

noisy, rattling breathing

rash with flat lesions or small raised lesions on the skin

shortness of breath

swelling of face, fingers, hands, feet, lower legs, or ankles

troubled breathing at rest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

Less common

Abdominal cramps

stomach soreness or discomfort

Rare

Agitation

back, leg, or stomach pains

bleeding gums

blistering, peeling, loosening of skin

blood in urine or stools

bloody, black, or tarry stools

blurred vision

burning feeling in chest or stomach

change in vision

chest pain

chills

clay-colored stools

coma

confusion

constipation

cough or hoarseness

dark urine

decreased urine output

depression

difficulty breathing

difficulty swallowing

dilated neck veins

dizziness

dry mouth

extreme fatigue

fast, irregular, pounding, or racing heartbeat or pulse

fever with or without chills

frequent urination

general body swelling

general feeling of tiredness or weakness

hair loss, thinning of hair

headache

hives or welts

hostility

impaired vision

increased blood pressure

increased volume of pale, dilute urine

irregular breathing

irritability

itching

joint or muscle pain

lab results that show problems with liver

lethargy

light-colored stools

loss of appetite

lower back or side pain

muscle twitching

nosebleeds

painful or difficult urination

pains in stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rash

red skin lesions, often with a purple center

red, irritated eyes

redness of skin

seizures

severe abdominal pain, cramping, burning

severe and continuing nausea

sore throat

sores, ulcers, or white spots in mouth or on lips

stiff neck or back

stomach upset

stupor

swollen or painful glands

tenderness in stomach area

thirst

tightness in chest

unpleasant breath odor

upper right abdominal pain

vomiting of blood

vomiting of material that looks like coffee grounds

wheezing

yellow eyes and skin

Symptoms of overdose

Bluish lips or skin

difficulty sleeping

disorientation

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

drowsiness to profound coma

hallucination

lightheadedness or fainting

mood or other mental changes

muscle tremors

not breathing

rapid, deep breathing

restlessness

slow or irregular heartbeat

stomach cramps

sudden fainting

sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Continuing ringing or buzzing or other unexplained noise in ears

hearing loss

nervousness

Rare

Crying

depersonalization

discouragement

dry eyes

dysphoria

euphoria

feeling sad or empty

lack of appetite

loss of interest or pleasure

mental depression

paranoia

quick to react or overreact

rapidly changing moods

runny nose

sleepiness or unusual drowsiness

sleeplessness

sneezing

stuffy nose

trouble concentrating

trouble sleeping

unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Osteoarthritis

Comments: -Patients with rheumatoid arthritis may require higher doses than those with osteoarthritis. -Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals. -Patients treated with 3200 mg orally per day should be observed for sufficient increased clinical benefits to offset potential increased risk.

Use: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Comment: -There are multiple over-the-counter formulations with different concentrations of the oral suspension and capsule/tablet strengths; manufacturer labeling may be consulted for weight/age based dosing charts.

Use: For the relief of fever

Usual Pediatric Dose for Patent Ductus Arteriosus

Ibuprofen lysine (NeoProfen[R]):Gestational age 32 weeks or less and weight between 500 and 1500 g: -Initial dose: 10 mg/kg IV -Following initial dose, two doses of 5 mg/kg each, after 24 and 48 hours -If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.

Comments: -A course of therapy is defined as 3 doses; if ductus arteriosus closes or has significantly reduced in size after completion of the first course, no further doses are needed. -If during continued medical management the ductus arteriosus fails to close or reopens, then a second course, alternative pharmacological therapy, or surgery may be needed.

Use: For the closure of a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective (e.g., fluid restriction, diuretics, respiratory support, etc.). The clinical trial was conducted in infants with asymptomatic PDA; however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS: -Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. -This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. -NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

IV Ibuprofen (Caldolor[R]) and Oral Suspension: Safety and efficacy have not been established in patients younger than 6 months.

Over the Counter Capsules and Tablets: Safety and efficacy have not been established in patients younger than 12 years.

Over the Counter Chewable Tablets and Suspension: Safety and efficacy have not been established in patients younger than 6 months.

Oral Prescription Tablets: Safety and efficacy have not been established in patients younger than 18 years.

Ibuprofen Lysine (NeoProfen[R]): Safety and efficacy have not been established in patients younger than 32 weeks gestational age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Administrative Information

LactMed Record Number

142

Last Revision Date

20160204

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